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Managing Immunogenicity Using Quantitative Systems Pharmacology

The Challenge of Immunogenicity in Biologics Drug Development Biologic drug development is a rapidly evolving…

CertaraFebruary 22, 2019

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Define.xml Frequently Asked Questions

Discover answers to common Define.xml FAQs, covering best practices, expert tips, and essential guidance for…

CertaraDecember 10, 2018

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7 Things to Know About the China Pharmaceutical Industry

China is the second largest pharmaceutical market in the world. Demand is likely to increase…

CertaraOctober 16, 2018

Blog

FDA’s New ANDA Submissions Guidance: Key Points

The U.S. Food and Drug Administration (FDA) published notice of a new ANDA submissions guidance…

CertaraSeptember 27, 2018

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Overcoming Pitfalls and Challenges with Software Validation

As a quality consultant and quality system subject matter expert in the Life Sciences Industry…

CertaraJune 29, 2018

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Achieving Compliance with the FDA’s eCTD Mandate

The US Food and Drug Administration (FDA) has set May 5, 2018 as the compliance…

CertaraMay 4, 2018

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Using a Pharmacology to Payer Framework to Support Product Development

Modeling and simulation (M&S) of complex systems has primarily advanced vertically in differing scientific domains…

CertaraMarch 16, 2018

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Skin in the Game: Mechanistic Modeling of Dermal Drug Absorption

The ability to estimate systemic exposure from dermal absorption is essential in developing new dermatological…

CertaraMarch 2, 2018

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Surveying the Lay of the Land for Modeling & Simulation for Global Regulatory Submissions

Analogous to how a geologist surveys the “lay of the land” to determine if oil…

CertaraFebruary 16, 2018

Blog

Using PBPK Models to Assess Fetal Drug Exposure

The tragedy of thalidomide provides a cautionary tale about the potential for birth defects resulting…

CertaraJanuary 19, 2018

Blog

Managing Immunogenicity Using Quantitative Systems Pharmacology

Define.xml Frequently Asked Questions

7 Things to Know About the China Pharmaceutical Industry

FDA’s New ANDA Submissions Guidance: Key Points

Overcoming Pitfalls and Challenges with Software Validation

Achieving Compliance with the FDA’s eCTD Mandate

Using a Pharmacology to Payer Framework to Support Product Development

Skin in the Game: Mechanistic Modeling of Dermal Drug Absorption

Surveying the Lay of the Land for Modeling & Simulation for Global Regulatory Submissions

Using PBPK Models to Assess Fetal Drug Exposure

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